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2011 Annual Report

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2011 Annual Report UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ⌧ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2011 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR o SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report For the transition period from __________ to __________ Commission file number _______________ BioLineRx Ltd. (Exact name of Registrant as specified in its charter) (Translation of Registrant’s name into English) Israel (Jurisdiction of incorporation or organization) P.O. Box 45158 19 Hartum Street Jerusalem 91450, Israel (Address of principal executive offices) Philip Serlin +972 (2) 548-9100 +972 (2) 548-9101 (facsimile) [email protected] P.O. Box 45158 19 Hartum Street Jerusalem 91450, Israel (Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) Securities registered or to be registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registered American Depositary Shares, each representing 10 Nasdaq Capital Market ordinary shares, par value NIS 0.01 per share Ordinary shares, par value NIS 0.01 per share Nasdaq Capital Market* *Not for trading; only in connection with the registration of American Depositary Shares. Securities registered or to be registered pursuant to Section 12(g) of the Act. None (Title of Class) Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None (Title of Class) Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report. 123,603,141 Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No ⌧ If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Yes o No ⌧ Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections. Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ⌧ No o Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o No o Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one): Large accelerated filer o Accelerated filer o Non-accelerated filer ⌧ Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing: U.S. GAAP o International Financial Reporting Standards as issued by the Other o International Accounting Standards Board ⌧ If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. N/A Item 17 o Item 18 o If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No ⌧ (APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS) Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. N/A Yes o No o TABLE OF CONTENTS Page INTRODUCTION ii PART I ITEM 1. Identity of Directors, Senior Management and Advisers 1 ITEM 2. Offer Statistics And Expected Timetable 1 ITEM 3. Key Information 1 ITEM 4. Information on the Company 25 ITEM 5. Operating and Financial Review and Prospects 62 ITEM 6. Directors, Senior Management and Employees 76 ITEM 7. Major Shareholders and Related Party Transactions 91 ITEM 8. Financial Information 92 ITEM 9. The Offer and Listing 93 ITEM 10. Additional Information 94 ITEM 11. Quantitative And Qualitative Disclosure on Market Risk 107 ITEM 12. Description of Securities Other Than Equity Securities 108 PART II ITEM 13. Defaults, Dividends and Delinquencies 111 ITEM 14. Material Modifications to the Rights of Security Holders and Use of Proceeds 111 ITEM 15. Controls and Procedures 111 ITEM 16. [Reserved] 112 ITEM 16A. Audit Committee Financial Experts 112 ITEM 16B. Code of Ethics 112 ITEM 16C. Principal Accountant Fees And Services 112 ITEM 16D. Exemptions From The Listing Standards For Audit Committees 112 ITEM 16E. Purchases Of Equity Securities By The Issuer And Affiliated Purchasers 112 ITEM 16F. Change in Registrations Certifying Accountant 112 ITEM 16G. Corporate Governance 113 PART III ITEM 17. Financial Statements 114 ITEM 18. Financial Statements 114 ITEM 19. Exhibits 115 SIGNATURES 117 i INTRODUCTION Certain Definitions In this annual report, unless the context otherwise requires: • references to “BioLineRx,” “us,” “we” and “our” refer to BioLineRx Ltd. (the “Registrant”), an Israeli company, and its consolidated subsidiaries; • references to “ordinary shares,” “our shares” and similar expressions refer to the Registrant’s Ordinary Shares, NIS 0.01 nominal (par) value per share; • references to “ADS” refer to the Registrant’s American Depositary Shares; • references to “dollars,” “U.S. dollars” and “$” are to United States Dollars; • references to “shekels” and “NIS” are to New Israeli Shekels, the Israeli currency; • references to the “Companies Law” are to Israel’s Companies Law, 5759-1999, as amended; and • references to the “SEC” are to the United States Securities and Exchange Commission. Forward-Looking Statements Some of the statements under the sections entitled “Item 3. Key Information — Risk Factors,” “Item 4. Information on the Company,” and “Item 5. Operating and Financial Review and Prospects” and elsewhere in this Annual Report on Form 20-F constitute forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements, but these are not the only ways these statements are identified. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. In addition, the section of this Annual Report on Form 20-F entitled “Item 4. Information on the Company” contains information obtained from independent industry and other sources that we have not independently verified. You should not put undue reliance on any forward-looking statements. Unless we are required to do so under U.S. federal securities laws or other applicable laws, we do not intend to update or revise any forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: • the initiation, timing, progress and results of our preclinical studies, clinical trials, and other therapeutic candidate development efforts; • our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; • our receipt of regulatory approvals for our therapeutic candidates, and the timing of other regulatory filings and approvals; • the clinical development, commercialization, and market acceptance of our therapeutic candidates; • our ability to establish and maintain corporate collaborations; • the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our therapeutic candidates in preclinical studies or clinical trials; • the implementation of our business model, strategic plans for our business and therapeutic candidates; • the scope of protection we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and our ability to operate our business without infringing the intellectual property rights of others; • estimates of our expenses, future revenues, capital requirements and our needs for additional financing; • competitive companies, technologies and our industry; and • statements as to the impact of the political and security situation in Israel on our business. ii PART I ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS Not applicable. ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Not applicable. ITEM 3. KEY INFORMATION A. Selected Financial Data The following table sets forth our selected consolidated financial data for the periods ended and as of the dates indicated. The following selected historical consolidated financial data for our company should be read in conjunction with “Item 5.
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